The posting
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
As a Staff QA Engineer your role will be responsible for defining requirements and development of analytic dashboards, validating, and deploying Quality Assurance data and information dashboards with focus on Manufacturing Controls, Quality Management Systems and New Product Development. This role is also responsible for executing and coordinating Site Management Reviews for the San Diego site and coordinating data transfer for Corporate Management Reviews. Also, this role leads and coordinates the Non-Conforming Events (NCE), support Internal and External Audits. This position will interface with different cross functional groups (Operations Data Analytics, Customer Advocacy, Quality Engineering, Software Engineering, Software Test, Regulatory Affairs, and others). The Staff Quality Engineer role provides Quality Assurance Engineering and Compliance expertise, and technical support to Sustaining Quality Engineering and Quality Control teams to ensure they have the necessary information to make quality decisions, facilitate compliance to Dexcom’s Quality Management System and international regulation standards (e.g. 21 CFR Part 11, 801, 803, 820; ISO 13485, ISO 14971).
Where you come in:
- Leads the design, development, validation, and deployment of Quality Assurance Metric Dashboards for all areas of Operations Quality Assurance in San Diego.
- Leads and coordinates the Non-Conforming Events (NCE) system.
- May administer specific aspects of the quality system.
- Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
- Participates in internal and external audits to ensure systems comply with requirements and are effective.
- Participates as a member of design teams representing Quality Assurance. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
- Apply risk management, validation, sample size, and external standards review and implementation activities.
- Coordinates the disposition of nonconforming materials with the Materials Review Board.
- Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
- QA Continuous Improvement Projects
- Assumes and performs other duties as assigned.
What makes you successful:
- Direct experience with Quality Management Systems, Nonconforming Material, CAPA, HHA/HHE, Nonconforming Events, Internal and External Audits.
- Good understanding of QMS as applied to medical devices.
- Direct experience developing dashboards in Power BI, Tableau,
- Experience with Oracle, Camstar, IQVIA, 1Factory, EtQ Reliance, SQL Servers, Google Big Query.
- Experience with statistical analysis and statistical analysis software packages like Minitab and Jump
- Experience in FDA audits
- Collaborative, able to work effectively and lead diverse functional groups.
- Demonstrates good judgment in selecting methods and techniques for problem solving and obtaining solutions.
- Can work well alone, normally receives little instruction on day-to-day work, general instructions on new assignments.
- A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
- Certified Quality Engineer, Certified Quality Auditor a plus.
What you’ll get:
- A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
- 0-5%
Experience and Education Requirements:
• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8-12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [email protected].
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected].
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$111,100.00 - $185,100.00
